Pharmacovigilance Coordinator

The Pharmacovigilance Coordinator is responsible for maintaining and managing the Pharmacovigilance System of Stragen Group in compliance with PV requirements and acts as the contact person for the Stragen’s global PV activities.

Requirements

• Acting as the designated contact person for global PV/vigilance system and activities.
• Ensure coordination of PV activities at Global level, in contact with the QPPV and all the affiliates of the Group.
• Ensure management of Medical Information system
• Establishment and maintenance of the Stragen’s Pharmacovigilance system for the products (PSMF)
• Ensure that pharmacovigilance activities and the submission of all pharmacovigilance-related documents is in accordance with the legal requirements and GVP.
• Ensure safety data reconciliations with Stragen partners and service providers.
• Perform initial and periodic qualification of PV partners: audits (agenda, audit reports and CAPA plans follow-up).
• Participate in Change Control process by providing the PV feedback.
• Inspection readiness, act as the point of contact in case of PV audit or inspection and coordinate the PV audit program, preparation, execution and CAPA plan implementation.
• Maintain awareness of Pharmacovigilance regulatory requirements and update the related company standard operating procedures and instructions as required.
• Maintain training materials and ensure initial and periodical PV training of Stragen personnel.
• Ensure the performance of the PV system through the follow-up of PV metrics and KPIs.
• Provide oversight to the QPPV on all the listed PV activities.
• Perform other duties as assigned.